Cannula For Organ Perfusion

System, Perfusion, Kidney

Bridge To Life Ltd.

The following data is part of a premarket notification filed by Bridge To Life Ltd. with the FDA for Cannula For Organ Perfusion.

Pre-market Notification Details

Device IDK203262
510k NumberK203262
Device Name:Cannula For Organ Perfusion
ClassificationSystem, Perfusion, Kidney
Applicant Bridge To Life Ltd. 128 Suber Rd., Suite A Columbia,  SC  29210
ContactBrett Schultz
CorrespondentH Carl Jenkins
Wood Burditt Group 10 E Scranton Ave, Ste 201 Lake Bluff,  IL  60044
Product CodeKDN  
CFR Regulation Number876.5880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-05
Decision Date2021-07-01

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